[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558747":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":33,"locations":41,"responsibleParty":56,"collaborators":24,"id":59,"slug":24,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":24,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":85,"whyStopped":24,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Bispebjerg Hospital","OTHER",[8,14],{"label":9,"type":6,"description":10,"interventionNames":11},"Randomized to start with Semaglutide intervention in study period 1","Placebo will be given in study period 2",[12,13],"Drug: Semaglutide, 0.5 mg\u002FmL","Drug: Placebo, Saline",{"label":15,"type":6,"description":16,"interventionNames":17},"Randomized to start with Placebo intervention in study period 1","Semaglutide will be given in study period 2",[12,13],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Semaglutide, 0.5 mg\u002FmL","1 subcutaneous injection on baseline day",[15,9],null,{"type":20,"name":26,"description":22,"armGroupLabels":27,"otherNames":24},"Placebo, Saline",[15,9],[29],{"name":30,"affiliation":31,"role":32},"Ali Asmar, MD, PhD","Bispebjerg Hospital, Department of Clinical Physiology & Nuclear Medicine","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Peter Sørensen, MD","CONTACT","+4530516279","peter.soerensen@regionh.dk",{"name":30,"role":36,"phone":24,"phoneExt":24,"email":40},"ali.asmar@regionh.dk",[42],{"facility":31,"status":24,"city":43,"state":44,"zip":45,"country":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Copenhagen","Capital Region","2400","Denmark",{"type":48,"coordinates":49},"Point",[50,51],12.56553,55.67594,{"lat":51,"lon":50},[54,55],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},{"name":30,"role":36,"phone":24,"phoneExt":24,"email":40},{"type":32,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Ali Asmar","Chief Physician, Associate Professor","100558747",false,"NCT06555146","Semaglutide's Effect on Renal Hemodynamics and Function in Patients With Type 2 Diabetes Mellitus and Nephropathy","Glucagon-like Peptide-1's Effect on Renal Regional Blood Flow and the Renal Function in Patients With Type 2 Diabetes Mellitus","Sema-RMA","Inclusion Criteria:\n\n* Type 2 diabetes mellitus diagnosed through either HbA1c ≥6,5% but ≤8,5%, or \\\u003C6,5% combined with either fasting plasma glucose ≥7,0 mmol\u002FL or plasma glucose ≥11,1 mmol\u002FL two hours after an oral glucose tolerance test (OGTT).\n* Estimated glomerular filtration rate (eGFR, CKD-EPI) between 30-60 mL\u002Fmin\u002F1.73m2\n* Urine Albumin:Creatinine ratio (UACR) ≥30mg\u002Fg\n* Stable RAAS blockade (ACE inhibitors or angiotensin II receptor blocker (ARB) with stable dosis for 4 weeks prior to screening)\n* Discontinuation of treatment with selective sodium glucose transporter inhibitors (SGLT2i), dipeptidyl peptidase 4 inhibitors (DPP-4i), GLP-1R analogs, rapid-acting and mix insulin 30 days before screening.\n\nExclusion Criteria:\n\n* Immunosuppressive therapy within 30 days of screening\n* Alcohol abuse\n* Medical treatment with glucocorticoids\n* Kidney transplantation\n* Treatment for renal failure with dialysis\n* Myocardial infarction within 3 months of screening\n* Heart failure (NYHA 3-4)\n* Dysregulated arterial hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥ 100 mm Hg)\n* Liver disease (ALAT \\>2 x normal value)\n* Conditions which may interfere with the glucose metabolism according to the PI\n* Severe claustrophobia\n* Elements incompatible with MRI\n* Abnormal kidney size and\u002For position\n* Venous and arterial anatomy hindering catheterization.","MALE","20 Years","60 Years",{"count":70,"type":71},15,"ESTIMATED","INTERVENTIONAL",[74],"NA","The goal of this double-blinded, placebo-controlled, randomized, crossover study is to examine the effect of semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), on renal hemodynamics and function in patients with type 2 diabetes mellitus (T2DM) and moderate chronic kidney disease (CKD).\n\nThe study will determine the effects of semaglutide on:\n\n* Renal arterial blood flow, regional renal perfusion, and oxygenation\n* Activity of the renin-angiotensin-aldosterone system (RAAS)\n* The glomerular filtration rate (GFR)\n* Sodium excretion in urine\n* Blood pressure and heart rate",[77,78],"Diabetes Mellitus, Type 2","Kidney Disease, Chronic",[80,81,82,83,84],"Renal flow","Regional renal perfusion","Sodium excretion in urine","Renin angiotensin aldosterone system","Glomerular filtration rate","NOT_YET_RECRUITING","2024-08-12",{"date":88,"type":89},"2024-08-15","ACTUAL",{"date":91,"type":71},"2024-08",{"date":93,"type":71},"2025-03",{"name":5,"class":6},1]